Conjunctivochalasis is an age-related disease caused by an excessively loose bulbar conjunctiva and/or high tension of the inferior lid margin.1 It is characterized by an accumulation of bulbar conjunctiva between the globe, the inferior lid margin, and the internal and external angles of the eye, leading to ocular surface and tear abnormalities. Patients typically complain of symptoms such as weeping, dryness, and foreign body sensations, among other symptoms2-5 severe conjunctivochalasis often accompanies dry eye due to disturbances in lacrimal dynamics.6
Few data have been published to date that describe the epidemiology of conjunctivochalasis. In a Japanese hospital-based study conducted by Mimura and associates, the prevalence of conjunctivochalasis was reported 85.24% based on 1416 cases aged from 1 to 94 years.1 In 2011, we described a community-based epidemiology study on 2110 Chinese residents over 60 years of age and found a conjunctivochalasis prevalence rate of 44.08%,7 which is much lower than that reported in the previous Japanese study. Differences in the research subjects used in Mimura's study and our study may be one reason for the apparent disparity between the prevalence rates; nevertheless, we doubt that the different diagnostic and grading systems used in the two studies played a critical role in the disparity. In 1998, Meller and Tseng proposed a diagnostic and grading system (4-level system, abbreviated here as Meller's system) for conjunctivochalasis,8 which was subsequently globally used by clinical researchers.6,9 Mimura and associates used Meller's system, which was mainly based on the lid-parallel conjunctival folds, punctual occlusion, and conjunctival fold changes during downgaze and digital pressure.1 We used a 5-level system (abbreviated here as Zhang's system) modified from Meller's system and included the conjunctival folds, dryness, foreign body sensations, epiphora symptoms, punctual occlusion, tear meniscus height, tear film break-up time (BUT), and conjunctival fold changes during downgaze. Grades II, III, and IV conjunctivochalasis in our grading system are also defined as “clinically significant conjunctivochalasis”.7
To elucidate the disparity between these two diagnostic and grading systems regarding the diagnosis of conjunctivochalasis in the general population, we organized a cross-sectional investigation of a senile population of subjects who were at least 60-years old and living in the Guiyangyuan community of Shanghai from April 1 to April 30, 2011. This report presents (1) the diagnostic results for conjunctivochalasis based on Meller's system and our system in the same community-based population and (2) an investigation of the patients' preferences for the treatment of conjunctivochalasis. The proper linkage between different grading results and patients' preferences is then discussed.
The Guiyangyuan community is located in the central part of Shanghai. A population census conducted at the end of 2007 showed that a stable urban population of 5020 people was living in this community. Among them, 1988 were senile residents aged 60 years or older, accounting for 39.6% of the total population. The average annual income of these residents was at the median level against that of Shanghai residents.
The calculation of the required sample size was performed by estimating the 95% confidence interval (CI) for the prevalence of clinically significant conjunctivochalasis within a limit of ±15% error. Based on our previous study, the proportion of persons (age ≥60 years) who were diagnosed as having conjunctivochalasis was estimated to be 0.4408.7 With simple random sampling, the required sample size can be calculated as n=Z2(p)(1p)/B2, where P=0.4408, the 15% error, as presented by B, is 0.4408 (0.15)=0.06612, and for a 95% CI, Z=1.96. It was assumed that a cluster design effect as high as 2.0 might be present, which increases the calculated sample size from 217 to 433. With an estimated response rate of 90%, the required sample size was 481.
A cluster sampling method was used for this investigation. Twenty subordinate groups, including 200-400 residents each, from the community, were randomly selected for sampling. Using a random number table, subordinate groups were finally selected as candidates for this study, and 580 residents who were 60 years or older and who had been living in this community for at least 6 months were distributed into these groups.
The field investigation was performed in the ophthalmic outpatient clinics of Putuo Hospital affiliated to Shanghai Traditional Medicine University, from April 1 to April 30, 2011. The study team included one lead ophthalmic doctor who had prior experience organizing large-scale epidemiologic studies, two trained ophthalmic doctors as the investigators, two assistant ophthalmic doctors, and three assistant physicians. Volunteers from the local community government helped to inform each participant of the study through oral and written notice.
The field investigations were conducted from 8:00 am to 4:00 pm each day in the study. First, the assistant physician collected general information from the study candidates, including their name, gender, birth date, race, and educational level. The assistant ophthalmic doctors then documented eye symptoms, determined the visual acuity of both eyes using the Snellen chart, and measured the intraocular pressure with a non-contact tonometer (NT-2000, Nidek Co. Ltd., Aichi, Japan). Then, with the eyes focused horizontally straight ahead, the two investigators independently examined each candidate's eyelids, conjunctiva, and cornea, as well as the position, height, and location of the lid-parallel conjunctival folds, the punctual point, the tear meniscus height, the tear film breaking-up time (BUT), and the height/extent of chalasis changes during downgaze, using slit-lamp biomicroscopy. The diagnosis was determined, and the classification and type of conjunctivochalasis of each eye were recorded. Any discrepancies between the two doctors were adjudicated by the independent lead ophthalmic doctor. Finally, the participants' preference regarding medical treatment for conjunctivochalasis was determined according to the response to the question of whether he or she intended to pursue treatment through medication or surgery. One year later, a follow-up interview to determine whether the patient had undergone surgery for conjunctivochalasis,10,11 such as superficial cauterization of the conjunctiva, crescent excision of the bulbar conjunctiva, and conjunctival sectorial peritomy, in the past year was conducted for all of the participants. All of the information obtained was documented and checked by the lead ophthalmic doctor.
The study was carried out with the approval of the Institutional Review Board and permission of the ethics committee (No. 2009-4) of Putuo Hospital affiliated to Shanghai Traditional Medicine University and was performed in accordance with the Declaration of Helsinki (1975) and its 1983 revision. Every resident provided written informed consent for inclusion in the study.
Diagnosis and classification criteria
If either of the two eyes was diagnosed with conjunctivochalasis, the patient was recorded as a conjunctivochalasis patient. Diagnostic criteria for conjunctivochalasis were based on two diagnostic and grading systems. The first diagnostic and grading system was previously used in the study by Mimura and associates.1 The details of the grading criteria were as follows: grade 0 (no persistent fold), grade I (a single, small fold), grade II (two or more folds, but not higher than the tear meniscus), and grade III (multiple folds and higher than the tear meniscus). Grading was carried out separately for the temporal, middle, and nasal areas of the conjunctiva. In addition, the extent of conjunctivochalasis, gazedependent changes, and digital pressure-dependent changes were classified according to Meller's system. The extent of the redundant conjunctival folds was classified as follows: (0)=none, L(1)=one location, L(2)=two locations, and L(3)=the entire eyelid. For L(1) and L(2), the location was specified further as T, M, or N if conjunctivochalasis was found at the temporal, middle (or inferior to the limbus), or nasal part of the lower lid, respectively. At each location, conjunctivochalasis was graded further as G (-1), G (0), or G (1) if it improved, was unchanged, or became worse with a downward gaze, respectively. The conjunctivochalasis was also graded as P (0) or P (1) if it was unchanged or became worse with digital pressure, respectively. Although data were obtained from each location, only the data for the nasal conjunctiva were used for the analysis. Superficial punctate keratitis localized to the lower lid margin was classified as absent (grade S (0)) or present (grade S (1)).
The second diagnostic grading system for conjuncti vochalasis was modified from Meller's system, and we used this system in our previous study (abbreviated here as Zhang's system).7 Detailed information on this system is provided in Table 1. The location of conjunctivochalasis was specified as T, M, or N, similarly to Meller's system, if conjunctivochalasis was found in the temporal, middle (or inferior to the limbus), or nasal aspect of the lower lid, respectively. Grade criteria F (folds versus tear meniscus height) were set as the basic grading criteria, regardless of whether the conjunctival fold was present in any of the three locations. The height of the tear meniscus was measured by calibration on the slit lamp. The normal value was set as greater than or equal to 0.3 mm. Typical views of eyes of different grades according to this grading system for conjunctivochalasis are provided in Figure 1.
Before the field investigation, the lead ophthalmic doctor trained the two investigators in the examination methods, diagnosis, and grading criteria using photographs of typical cases of conjunctivochalasis. After training, the two investigators checked and recorded the diagnosis of conjunctivochalasis in 30 eyes of 15 randomly selected people. The investigators' grading results for conjunctivochalasis were found to be highly consistent when either Meller's system (κ=0.82) or Zhang's system (κ=0.93) was used.
The prevalence rates of the general characteristics of the conjunctivochalasis patients and non-conjunctivochalasis patients were compared using the Pearson line × list χ2 test or the tendency χ2 test. The tests were considered to be statistically significant at P <0.05 (SPSS 10.0; SPSS, USA). The Snellen fractions were converted to a log scale (LogMAR) for statistical analysis using the method of Holladay and Prager.12 The t-test was utilized to compare the LogMAR vision of conjunctivochalasis eyes and non-conjunctivochalasis eyes.
A total of 546 residents who were at least 60 years old participated in and completed the study, with an inclusion rate of 94.13% (546/580). Of these subjects, 207 were male and 339 were female. The age of these 546 participants ranged from 60 to 85 years, with an average of (72±7) years. One eye of a participant was enucleated several years before the study; therefore, a total of 1091 eyes from the 546 participants were included in this study. The average LogMAR visual acuity of the 1091 eyes was 0.56±0.33. The average intraocular pressure of the 1091 eyes was (15.4±3.4) mmHg.
A total of 398 participants were confirmed as having conjunctivochalasis with Meller's system; therefore, the prevalence rate of conjunctivochalasis was 72.89%. However, with Zhang's system, 213 participants were diagnosed with conjunctivochalasis, and the prevalence rate was 39.01%. No statistically significant difference was found for the average age between the conjunctivochalasis participants and the remaining non-conjunctivochalasis participants when either Meller's system or Zhang's system (all P >0.05) was used.
With Meller's system, 740 eyes were diagnosed as having conjunctivochalasis, but only 410 eyes were diagnosed as having conjunctivochalasis using Zhang's system. With each system, the proportion of eyes with conjunctivochalasis increased gradually with age, as shown in Table 2. The average LogMAR visual acuity and the average intraocular pressure did not differ significantly between the conjunctivochalasis participants and the remaining non-conjunctivochalasis participants, regardless of whether the diagnosis was made using Meller's system or Zhang's system (all P >0.05).
With Meller's system, 364 eyes were classified as grade I (33.36%), 221 eyes were classified as grade II (20.25%), and 155 eyes were classified as grade III (14.20%). With Zhang's system, 217 were classified as grade I (19.89%), 138 were classified as grade II (12.64%), 37 were classified as grade III (3.39%), and 18 were classified as grade IV (1.64%). The diagnostic and grading results for all of the participants' eyes obtained using each of the two systems are shown in Table 3. However, the grading results obtained with the two systems were different.
A total of 84 participants who were diagnosed with conjunctivochalasis indicated that they would seek medical treatment or surgery to relieve his or her condition. After 1 year, according to the follow-up review, 61 participants had used medication and 23 had undergone surgery for conjunctivochalasis, resulting in a total of 109 treated eyes. Typical views of eyes before and after surgery for conjunctivochalasis were provided in Figure 2. The diagnostic and grading results obtained using both systems for all 109 eyes were shown in Table 4.
The investigation of conjunctivochalasis in different populations has led to different study results. When Meller's system is used, the prevalence rate of conjunctivochalasis among the Guiyangyuan community residents (72.89%) is lower than that reported by Mimura and associates, which was conducted with a Japanese hospital-based population (98.5%). Nevertheless, different diagnostic criteria may lead to greater differences in the study results. According to Zhang's system, the prevalence rate was as low as 39.01% in the Guiyangyuan community residents. Because Meller's system and Zhang's system use the same basic grading criteria (folds vs. tear meniscus height) and the distinctions between the two systems only address the types of symptoms and tear film BUT, we propose that the symptoms of conjunctivochalasis are not aggravated coincidentally with redundant conjunctiva worsening. For instance, only 27.54% of the residents who were scored as grade II according to Zhang's system were classified as grade II according to Meller's system.
As found in previous studies,7,8 conjunctivochalasis was confirmed to be an age-related disease in the present study. Therefore, the diagnostic criteria of conjunctivochalasis should show a clear distinction between patients and healthy people in the aging population. According to Meller's system, grade I conjunctivochalasis only indicates a single, small fold, which often occurs as a normal aging variation. Grade II indicates two or more folds that are not higher than the tear meniscus, which also occurs in normal persons more than 70 years of age. In the present study, all the patients with grade I and 96.39% with grade II conjunctivochalasis based on Meller's system were reluctant to seek medical treatment for their condition (Table 5); thus, we infer that some asymptomatic, healthy older people could be diagnosed with grades I and II conjunctivochalasis according to Meller's system, accounting for the high proportion of patients with conjunctivochalasis (98.5%) that was reported in the study by Mimura and associates.1 With Zhang's system, the clinical manifestation of grade I conjunctivochalasis includes not only the redundant conjunctival fold sign but also the patients' symptoms, and a grade I patient would be recommended to receive regular check-ups to reduce the risk factors of conjunctivochalasis. A certain proportion (39.85%) of grade II patients, according to Zhang's system, who suffered from moderate symptoms and/or abnormal tear appearance reported that they intended to seek medical help.
In Meller's system, grade III is intended to represent severe patients.8 However, no more than 66% of the patients classified as grade III based on Meller's system indicated that they would seek medical treatment for their discomfort. Therefore, we doubt that medical recommendations based only on conjunctiva sign will be accepted by Meller's grade III patients. Zhang's grade III patients, who suffer from severe discomfort and unstable tear film, were all recommended for pharmacotherapy or even surgery, and most of them (83.78%) reported that they were willing to accept doctors' advice. When modifying Meller's system, Zhang and associates added grade IV, which corresponds to the most severe condition.7 In such cases, surgery is always mandatory and accepted by almost all patients.
Grades II, III, and IV stages in Zhang's system are defined as “clinically significant conjunctivochalasis.”7 In the present study, the patients with clinically significant conjunctivochalasis comprised approximately 17.88% of the total population, which is similar to the values reported in a previous study.7 We hope this prevalence rate will influence ophthalmic doctors when they encounter patients complaining of symptoms related to dry eye diseases, including a piled conjunctiva or an abnormal lacrimal river. It should be emphasized that common treatment methods for dry eye disease do not apply to severe conjunctivochalasis, which can only be treated with specialized surgery.8,13-15
The inherent weakness of the present study should not be neglected. We studied a specific group of residents living in a community nearby a large hospital, and most of them can afford the treatment for conjunctivochalasis. Future studies in another population, such as residents living in other cities than Shanghai, may help to verify the results of the present study.
With respect to the patient's preference for treatment, the grading and diagnostic results obtained with Zhang's system are more highly related to patients' desire for treatment and the medical treatment strategy than those obtained with Meller's system. Meller's system for conjunctivochalasis relies only on conjunctiva signs, while Zhang's system also includes criteria related to patients' complaints or dry eye symptoms, which are considered to be closely associated with conjunctivochalasis.1,6,8,9,16-18 Therefore, Zhang's system includes more characteristics of conjunctivochalasis and may be more useful for doctors when considering medical recommendations and treatment strategies. However, conjunctivochalasis is a complicated disease, and no grading system to date includes all of the possible elements for defining the severity of conjunctivochalasis. Furthermore, a consensus has not yet been reached on the diagnostic and grading system for conjunctivochalasis.5-8,19 In our future investigations, we hope to develop reliable and valid grading systems that will be globally accepted.
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Keywords:© 2013 Chinese Medical Association
conjunctivochalasis; diagnosis; grading system