Fundus Photograph Reading Center

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Appendix B October 10, 1997

Edit Specifications for MACRT Grading Forms:

Assessment of Ocular Photographs Forms B (Baseline), F (Follow-up)

Gridwork Form RE, LE

Note: The purpose of the following specifications is to specify the combinations of grades allowed by an edit for completeness and consistency within and across forms. When the relationships are expressed by cross-tabulations, an X in the cell corresponding to a given pair indicates that the pair is allowed.

"Assessment of Ocular Photographs," Primary Grading Form

General Completeness

The extent to which the form must be completed is governed by the "Photographs Present" item (I110). If no photographs are present (code 0), no further items are completed. If the only the red reflex or lens photo is present (code 1), no other item is completed except for the "Comments" item (I199) at the grader's discretion. If retinal photographs are present (code 2), the grader is required to complete the entire form.

For the baseline variant only, three questions regarding CMV retinitis border characterization are added: "Solid Border," (I371), "Satellite Border" (I381), and "Hemorrhagic Border (I391).

For the follow-up variant only, the "CMV Retinitis Progression" section is added, including "Movement since Baseline," Zone 1 and 2 questions (I421 and I422); "Movement since Last Visit," Zone 1 and 2 questions (I426 and I427); "New Spot since Baseline," Zone 1 and 2 questions (I441 and I442); and "New Spot since Last Visit," Zone 1 and 2 questions (I446 and I447). Four subsidiary items are included in the "CMV Retinitis Progression" section for the graders convenience in recording where progression was detected: "Fields with Movement since Baseline," "Fields with Movement since Last Visit," "Fields with New Spot since Baseline," "Fields with New Spot since Last Visit." For the "Movement" items, the corresponding "Field" items are completed only if the "Movement" item in either Zone 1 or Zone 2/3 has code 3 or higher (signifying at least 750 um). For the "New Spot" items, the corresponding "Field" items are completed only if the "New Spot" item in either Zone 1 or Zone 2/3 has code 3 (indicating at least 1/4 DA in extent).

Inter-item Relationships

Form page 1

Other Lesions Gatekeeper (I160) vs Subsidiary Items (I161-177) – Rule 07

The "Other Lesions" gatekeeper is marked code 2 only if one or more of the lesions governed by it are graded questionably (code 1) or definitely (code 2) present. The gatekeeper is marked 0 if all the lesions governed by it are absent or ungradable, the latter because the gatekeeper does not have a separate value for "cannot grade."

Form page 2

Since Zone 1 contains the disc and macula safety zones, the code for presence for the zone overall must be at least as high as the codes for presence in the safety zones.

CMVR Zone 1 (I201) vs. CMVR in Disc Safety Zone (I218) – Rule 08

CMVR Zone 1 (I201) vs. CMVR in Macula Safety Zones (I219)

CMVR must be present in order to display a stage of activity.

CMVR Zone 1 (I2201) vs Maximum Activity, Zone 1 (I228)

CMVR Zone 2/3 (I202) vs Maximum Activity, Zone 2/3 (I255)

To be included in the proportion of the lesion edge considered active, the stage of activity must be at least code 4 (equaling or exceeding the reference area in standard photograph 4) - which is perhaps the mildest stage of activity that would be clinically recognizable.

Maximum Activity in Zone 1 or Zone 2/3 (I228, I255) vs. Edge Proportion Active (I275)

The Maximum of Maximum Activity is determined as follows:

If one field is 8 then

if the other field is 0,1 or 2, 8 is the maximum;

if the other field is not 0,1 or 2, the other field is the maximum.

If no field is 8, the numerical maximum is the maximum.

Edge Proportion Active (I275) vs. Edge Proportion with Satellites (I285)

The intent of evaluating the edge proportion with (active) satellites is to identify cases with marked activity. Thus, only if the portion of the edge under consideration has at least code 4 activity can it be included in the proportion considered to have (active) satellites.

Form page 3

Distance to Disc (I331) vs Disc Involvement (I332) – Rule 15

Round value to nearest tenth.

Distance to Center of Macula (I341) vs. FAZ Involvement (I342) – Rule16

If the FAZ is involved with CMVR to some degree, the distance between the disc and the nearest CMVR lesion must be 0.167DD or less (0.2 DD or less, rounded to the nearest tenth), since the FAZ has a radius of about 250 um. For CMVR to involve at least half of the FAZ, the distance must be 0.1 DD or less.

Retinal Detachment Gatekeeper (I361) vs Retinal Detachment Subfields (I362,364,365-368)

If retinal detachment is questionable, definite, or ungradable in any of the subfields governed by the gatekeeper, the code selected for the gatekeeper must match the highest code assigned in any of the subfields.

When the gatekeeper is 0, all the subfields should be either 0 or empty.

When the gatekeeper is 8, the subfields should be a combination of 8, 0 or empty provided at least one subfield is 8 or empty.

When the gatekeeper is 1, no subfield can be empty and the maximum of the subfields should be 1. 8 is considered less than 0 in the comparison.

When the gatekeeper is 2, no subfield can be empty and the maximum of the subfields should be 2. 8 is considered less than 0 in the comparison.

Any Zone 1 Retinal Detachment (I364) vs FAZ Retinal Detachment (I362)

Since the FAZ is contained within Zone 1, the code selected for Zone 1 overall (any) must equal or exceed the code selected for the FAZ.

CMVR Border Characterization (Baseline Only)

Depth of Solid Border (I371) vs. Maximum of Maximum Activity (I228,I255)

In order for the depths of solid border and satellite border to be evaluated, the stage of activity must be evaluated as at least the mildest active stage (code 3).

The Maximum of Maximum Activity is determined as follows:

If one field is 8 then

if the other field is 0 , 1 or 2, 8 is the maximum;

if the other field is not 0, 1 or 2 , the other field is the maximum.

If no field is 8, the numerical maximum is the maximum.

Depth of Satellite Border (I381) vs. Maximum of Maximum Activity (I228, I255)

The Maximum of Maximum Activity is determined as follows:

If one field is 8 then

if the other field is 0, 1 or 2, 8 is the maximum;

if the other field is not 0, 1 or 2, the other field is the maximum.

If no field is 8, the numerical maximum is the maximum.

Hemorrhagic Border (I391) vs. Maximum of CMVR Zone 1 and Zone 2/3 Presence (I201, 202)

For hemorrhagic border to be evaluated as questionable or higher, CMVR has to be evaluated as at least questionably present.

The Maximum of Zone 1 and Zone 2/3 Presence is determined as follows:

If one field is 8 then

if the other field is 0, 8 is the maximum;

if the other field is not 0, the other field is the maximum.

If no field is 8, the numerical maximum is the maximum.

Form page 4

CMVR Progression (Follow-up Only)

Not only should the progression conclusions be compared with other items within the same visit (intra-form edit), they should also be compared with any previous follow-up visits (inter-form edit).

Intra-form Edit

Movement since Baseline vs. Movement since Last Visit, for Zone 1(I421, I426) and Zone 2/3 (I422, I427), taking into account New Spot since Baseline (I441 for Zone 1, I442 for Zone 2/3)

Movement since Last Visit cannot exceed Movement since Baseline, since the latter item is cumulative and retinopathy is considered irreversible, unless the movement being described is attributed to a new lesion (new spot) since baseline.

New Spot since Baseline vs New Spot since Last Visit, for Zone 1(I441,I446) and Zone 2/3 (I442,I447)

New Spot since Last Visit cannot exceed New Spot since Baseline, since the latter item is cumulative and retinopathy is considered irreversible.

Inter-Form Edit

Progression compared to baseline is considered to be irreversible, so that once progression has been noted, it must be declared at any later visits to an equal or greater degree (except for visits at which it cannot be determined - "cannot grade."

Movement since Baseline, Current vs Past Visits, for Zone 1(I421) and Zone 2/3 (I422)

New Spot since Baseline, Current vs Past Visits, for Zone 1(I441) and Zone 2/3 (I442)

Gridwork Form, RE and LE

Stop Conditions (I800) vs Stop Conditions for Zone 1 (I801), Zone 2 "Cookie Cutter" (I802), and Zone 2 Other (I803) – Rule 26

Since the main stop condition item governs the stop conditions for different regions of the retina, it must match the maximum of their values. The regions are Zone 1, Zone 2 "Cookie Cutter", and Zone 2 Other.

When the gatekeeper is 0, all the subfields should be empty.

When the gatekeeper is 1, all the subfields should be empty or 0.

When the gatekeeper is 8, the subfields should be a combination of empty, 8 or 0 provided that at least one subfield is 8 or empty.

When the gatekeeper is 2, no subfield can be empty and at least one subfield should be 2.

Stop Condition Zone 1 (I801) vs Maximum Zone 1 Subfields (I211-217) – Rule 27

Since the stop condition governs the subfields, their maximum value must match the value of the stop condition.

When the gatekeeper is 0, all the subfields should be empty or 0.

When the gatekeeper is 8, all the subfields should be empty or they can be empty, 8 or 0 provided that at least one subfield is 8.

When the gatekeeper is 2, the maximum of the subfields should be between 3 and 7. 8 is not considered in the comparison.

Stop Condition Zone 1 (I801) vs CMVR Zone 1 (I201) – Rule 28

The stop condition on the gridwork form must be consistent with the item on the primary form regarding presence of CMVR.

Stop Condition Zone 2 "Cookie Cutter" (I802) vs Zone 2 "Cookie Cutter" Presence (I241-I246)

Since the stop condition governs the subfields, their maximum value must match the value of the stop condition.

When the gatekeeper is 0, all the subfields should be empty or 0.

When the gatekeeper is 8, the subfields should a combination of empty, 8 or 0 provided that at least one subfield is 8 or empty.

When the gatekeeper is 2, the maximum of the subfields should be between 3 and 7. 8 is not considered in the comparison.

Stop Condition Zone 2 Other (I803) vs. Zone 2 Involvement Blocks (I811,831,841,851,861,871,881,891)

Since the stop condition governs the subfields, their maximum value must match the value of the stop condition.

When the gatekeeper is 0 or 8, all the subfields should be empty or 0.

When the gatekeeper is 2, no field can be empty

Stop Condition Zone 2 Other (I803) vs. Zone 2 CG Blocks (I812,832,842,852,862,872,882,892)

When the gatekeeper is 0, all the subfields should be empty or 0.

When the gatekeeper is 8, the subfields must be 15.

When the gatekeeper is 2, no field can be empty.

Stop Condition Zone 2 Other (I803) vs. Zone 3 Presence Blocks (I813,833,843,853,863,873,883,893)

When the gatekeeper is 0, all the subfields should be empty or 0.

When the gatekeeper is 8, the subfields can be a combination of empty, 0 or 8.

When the gatekeeper is 2, no field can be empty.

Stop Conditions Zone 2 CC and Other (I802,I803) vs CMVR Zone 2/3 (I202) - Rule 33

The stop conditions on the gridwork form must be consistent with the item on the primary form regarding presence of CMVR.

Disc Involvement (I332) vs Disc Safety Zone (I211) – Rule 34

FAZ Involvement (I342) vs CMVR Macula Safety Zone (I219) Rule35 {was I213} Not interform

Inter-Grading Edit

1^st Grading vs. 2^nd Grading for Movement since Baseline for Zone 1(I421) and Zone 2/3 (I422)

and Movement since Last Visit for Zone 1(I426) and Zone 2/3(I427)

1^st Grading vs. 2^nd Grading for New Spot since Baseline for Zone 1(I441) and Zone 2/3 (I442)

and New Spot since Last Visit for Zone 1(I446) and Zone 2/3(I447)

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29Feb2000